There were a total of three new FDA drug approvals in June that we deemed specific to the specialty market. In addition, there were six supplemental drug approvals. The FDA had assigned six new products for review.

Drugs included in this review are generally regarded by the industry as specialty drugs. Qualifiers may include anticipated administration by a professional, distribution by a specialty pharmacy or submission and reimbursement under the medical claim or Medicare Part B.

New Specialty Drug Approvals – New FDA drug approvals in June

Drug Name

Manufacturer

Route of Administration

Indication

Approval Date

FULPHILA™ (pegfilgrastim-jmdb) – Biosimilar to Neulasta®

Mylan

subcutaneous

Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs

June 4, 2018

BRAFTOVI™ (encorafenib)

Array Biopharma

Oral

Use in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation

June 27, 2018

MEKTOVI® (binimetinib)

Array Biopharma

Oral

Use in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation

In combination with pembrolizumab and carboplatin, for the first-line treatment of metastatic, non-squamous, non-small cell lung cancer

June 4, 2018

RITUXAN® (rituximab)

Genentech

Intravenous

Moderate to severe Pemphigus Vulgaris (PV) in adult patients

June 7, 2018

KEYTRUDA® (pembrolizumab)

Merck

Intravenous

Treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy

June 13, 2018

KEYTRUDA® (pembrolizumab)

Merck

Intravenous

Treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [Combined Positive Score (CPS) ≥10], or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status

June 19, 2018

AVASTIN® (bevacizumab)

Genentech

Intravenous

Use in combination with carboplatin and paclitaxel, followed by Avastin as single agent, for the treatment of patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection.

June 13, 2018

TECENTRIQ® (atezolizumab)

Genentech

Intravenous

Treatment of patients with locally advanced or metastatic urothelial carcinoma who: are not eligible for cisplatin-containing chemotherapy, and whose tumors express PDL1 (PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥5% of the tumor area), or are not eligible for any platinum-containing chemotherapy regardless of level of tumor PD-L1 expression.

PDUFA: Prescription Drug User Fee Act: a law passed in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process. By collecting the fee, the FDA is required to meet benchmarks related to the speed of the NDA/BLA review process

PDUFA Date: deadlines for the FDA to approve new drugs, typically 10 months from NDA/BLA completions, drugs selected for priority review may be allotted 6 months

Todd Cooperman

Todd Cooperman joined RJ Health in June 2016 as Vice President, Clinical Analytics. As Senior Vice President, Todd and his team work with our various clients to identify opportunities and solutions that result in improved medical drug spend and clinical management.